To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters. The measured effect is the correlation of the capsule transit time (hours) with the number of polyps and their size (in mm).

To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography (in patients which were referred after positive CTC examination). No quantitative data here, only qualitative comparison between the scanning of the inner surface of the colon by the 3 independedt imaging modalities. No statistical plan or sample size justification would be provided, as is convention for pilot studies.

To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test)

To collect data about the overall imaging of the colon internal surface during the passage of the capsule

To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography [CTC] (in patients which were referred after positive CTC examination)

Detailed Description

Study Title:

Outside USA [OUS] Pilot Multi-center prospective feasibility study

Objectives:

Primary:

To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test)

Secondary:

To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters.

To monitor the functionality of the activation mechanism and of the scanning circuitry (transmitter detectors).

To collect data about the overall imaging of the colon internal surface during the passage of the capsule

To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography (in patients which were referred after positive CTC examination)

To estimate the total radiation exposure to each patient.

To measure the distribution of the contrast material within the colon.

Design:

Prospective, Single arm, Multi-Center

Patient population:

Group A - First in Man:

Male and female subjects older than 50 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment.

The study population will be enriched with up to 45 patients with known polyps detected by CTC or colonoscopy, in addition to 15 patient of the device's normal cohort.

All patients that are eligible for enrollment in the study will be tested by FOBT (Fecal Occult Blood Test) After the Capsule test, they will be referred for optical colonoscopy as part of the study

Group B - CE Pilot:

Male and female subjects older than 50 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment.

All patients that are eligible for enrollment in the study will be tested by FOBT (Fecal Occult Blood Test) Those tested NEGATIVE will be offered to ingest the capsule. After the Capsule test they will be referred for optical colonoscopy Consenting patients with negative FOBT testing scheduled for clinically-indicated optical colonoscopy without contraindication to either Check-Cap System imaging or optical colonoscopy, and able to undergo the bowel preparation necessary for optical colonoscopy.

Sample Size:

Total of 60 patients in both groups: A:3-5 + B: 55-57 subjects.

Study Procedure:

st visit - recruitment and screening meeting with the Principal Investigator [PI]. Subject will receive the FOBT test kit with detailed instructions for executing the test.

nd visit - The FOBT kits will be analyzed in order to diagnose the presence of blood in the stool.

In patients with NEGATIVE result the PI will examine the bowel log form. If it is complete and the bowel frequency is not less than once per 2 days the subject will be asked to sign the Informed Consent Form [ICF] for ingesting the capsule.